FDA Product Code OLO: Orthopedic Stereotaxic Instrument
FDA product code OLO covers orthopedic stereotaxic instruments.
These are computer-assisted navigation systems that provide real-time spatial guidance during orthopedic joint and spine surgery. They help surgeons achieve precise implant placement and trajectory planning.
OLO devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Orthopedic panel. Neurological stereotaxic instruments are classified separately under product code HAW.
Leading manufacturers include THINK Surgical, Inc., Brainlab AG and Stryker Leibinger GmbH & Co KG.
FDA 510(k) Cleared Orthopedic Stereotaxic Instrument Devices (Product Code OLO)
About Product Code OLO - Regulatory Context
510(k) Submission Activity
423 total 510(k) submissions under product code OLO since 2009, with 423 receiving FDA clearance (average review time: 122 days).
Submission volume has remained relatively stable over the observed period, with 90 submissions in the last 24 months.
FDA Review Time
FDA review times for OLO submissions have been consistent, averaging 122 days recently vs 122 days historically.
OLO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →